Clinical Analysis of Suction Drainage in Cementless Hip Replacement

NCT ID: NCT04333264

Last Updated: 2020-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2020-02-29

Brief Summary

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Randomized prospective study assessing suction drainage in total hip arthroplasty. Group without drainage, 50 hips, compared with group with suction drainage, 50 hips. Both groups will be asses clinically (ROM scale, VAS), laboratory and radiology (USG). In the actually literature there are no benefits using closed suction drainage after primary total hip arthroplasty.

Detailed Description

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Conditions

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Arthropathy of Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups of patients with or without closed suction drainage after primary total hip arthroplasty.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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suction drainage

Patients will be dived with randomization in to two groups: with and without closed suction drainage after primary total hip arthroplasty

Group Type ACTIVE_COMPARATOR

suction drainage

Intervention Type PROCEDURE

After primary total hip arthroplasty closed suction drainage will be used.

no suction drainage

Patients will be dived with randomization in to two groups: with and without closed suction drainage after primary total hip arthroplasty

Group Type ACTIVE_COMPARATOR

no suction drainage

Intervention Type PROCEDURE

After primary total hip arthroplasty closed suction drainage won't be used.

Interventions

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suction drainage

After primary total hip arthroplasty closed suction drainage will be used.

Intervention Type PROCEDURE

no suction drainage

After primary total hip arthroplasty closed suction drainage won't be used.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age between 30-80
* primary hip osteoarthritis

Exclusion Criteria

* secondary hip osteoarthritis
* autoimmune disease
* congenital or secondary coagulopathy
* vein or artery thrombosis
* renal or liver failure
* cemented or hybrid alloplasty,
* no consent from the patient
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bartosz Paweł

OTHER

Sponsor Role lead

Responsible Party

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Bartosz Paweł

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Pawel Bartosz

Role: PRINCIPAL_INVESTIGATOR

Prof. A. Gruca Teaching Hospital in Otwock

References

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Bartosz P, Marczynski W, Para M, Kogut M, Bialecki J. Comparative study of suction drainage placement in cementless hip replacement among patients undergoing extended thromboprophylaxis: a prospective randomized study. BMC Musculoskelet Disord. 2021 Aug 13;22(1):688. doi: 10.1186/s12891-021-04583-0.

Reference Type DERIVED
PMID: 34389016 (View on PubMed)

Other Identifiers

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1/032016

Identifier Type: -

Identifier Source: org_study_id

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